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SL-START - SubLingual Apomorphine Schemes of TitrAtion in Real-world Treatment

NCT07145190 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2026-08-11

No results posted yet for this study

Summary

The purpose of the study is to generate real-world evidence data for the on-demand treatment with SL-APO, focusing on understanding its usage and titration practices including individual dose determination after dose-adjustment to ultimately understand their influence in patient satisfaction, treatment persistence, and the balance between effectiveness and safety. The data may help optimize titration approaches to better meet the patient's needs.

Conditions

  • Parkinson Disease

Interventions

DRUG

SL-APO

Patients should start with a dose of 10 mg SL-APO. Dose initiation should occur when the patient is having an OFF episode. If the patient tolerates the 10 mg dose, and responds adequately (meaning satisfactory motor response within 30 minutes), the maintenance dose should be 10 mg. If the dose is tolerated but the response is insufficient, continue to titrate in 5 mg increments when the patient is having an OFF episode and assess response until an effective and tolerable dose is achieved, up to a maximum of 30 mg per dose and up to five times a day. If an "ON" response is achieved and if clinically warranted, consider the need to further up-titrate as tolerated to achieve a better "ON" response. The minimal interval between doses is 2 hours, with no more than one dose of SL-APO per OFF episode.

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Principal Investigators

  • Jan Kassubek, Prof Dr med · Praxis für Neurologie und Geriatrie (Ulm)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-27
Primary Completion
2028-02-29
Completion
2028-02-29

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07145190 on ClinicalTrials.gov